MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, SPANISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-58

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during preventative maintenance by getinge field service engineer, the cs100 intra-aortic balloon pump (iabp) unit's power button sometimes fails.There was no patient involvement.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h4, h6(type of investigation, investigation findings, investigation conclusions), h10.Additional information: e1(event site postal code: (b)(6), event site state: (b)(6)).It was reported that the cs100 intra-aortic balloon pump (iabp) had power button sometimes fails.A getinge field service engineer (fse) evaluated the unit and resolved the issue by replacing cable assembly,power on/off.Fse then tested the safety and functionality as per factory specifications and iabp was then returned to customer for clinical use.

Event Description

N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, SPANISH, 220V
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 18413890
• MDR Text Key: 331582810
• Report Number: 2249723-2023-05520
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107622
• UDI-Public: 10607567107622
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-3013-58
• Device Catalogue Number: 0998-00-3013-58
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 05/16/2024
• Supplement Dates FDA Received: 05/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1